The TranQuill barbed device is a sterile, synthetic absorbable device that is intended for use in the approximation of soft tissue. It is comprised of polyester [poly (p-dioxanone)], dyed with D&C Violet No. 2. The device is designed with small bi-directional barbs along the long axis of the suture monofilament. It is available in diameter Size 0 through 2-0 in various lengths affixed to various needle types.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device called the TranQuill barbed device, an absorbable surgical suture. The focus of the documentation is to demonstrate substantial equivalence to a predicate device.

Here's an analysis of the acceptance criteria and the study based on the provided information:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria Category	Specific Acceptance Criteria (Inferred from testing)	Reported Device Performance
Material Composition	Comprised of Polydioxanone (PDO)	Comprised of Polydioxanone (PDO), dyed with D&C Violet No. 2
Design	Designed with small bi-directional barbs along the long axis of the suture monofilament	Designed with small bi-directional barbs along the long axis of the suture monofilament
Physical Dimensions	Available in diameter Size 0 through 2-0 in various lengths	Available in diameter Size 0 through 2-0 in various lengths
Sterility	Sterile	Sterile
Tensile Strength	Conforms to USP monograph for absorbable sutures	Conforms to USP monograph for absorbable sutures
In vitro Barb Holding Strength	Performance comparable to predicate device	Demonstrated substantial equivalence to predicate device in barb holding strength
Post-Hydrolysis Tensile Testing	Performance comparable to predicate device	Demonstrated substantial equivalence to predicate device in post-hydrolysis tensile strength
Intended Use	Soft tissue approximation where use of absorbable sutures is appropriate	Indicated for soft tissue approximation where use of absorbable sutures is appropriate
Biocompatibility	Not explicitly stated as a test, but implied by regulatory requirements for implantable materials	Not explicitly stated, but implied by use of PDO, a known biocompatible material

2. Sample Size Used for the Test Set and Data Provenance:

Sample Size: Not explicitly stated. The documentation mentions "Non-clinical laboratory performance testing," but does not provide specific sample numbers for each test (e.g., number of sutures tested for tensile strength).
Data Provenance: The testing was "Non-clinical laboratory performance testing," indicating it was conducted in a controlled lab environment. There is no information about the country of origin of the data or whether it was retrospective or prospective, as it pertains to benchtop testing rather than clinical data.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

Not applicable. This device is a surgical suture, and the evaluation focused on non-clinical laboratory performance testing to establish substantial equivalence to a predicate device. It did not involve a test set requiring expert interpretation or ground truth establishment in the context of diagnostic or screening performance.

4. Adjudication Method for the Test Set:

Not applicable. As the study involved non-clinical laboratory performance testing of physical characteristics, there was no need for an adjudication method as would be used in studies involving subjective expert opinions or diagnostic interpretation.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No, an MRMC study was not done. This type of study is typically performed for diagnostic or screening devices to assess human reader performance with and without AI assistance. The TranQuill device is a surgical product, not a diagnostic tool requiring interpretation by multiple readers.

6. Standalone (Algorithm Only Without Human-in-the-Loop) Performance:

Not applicable. The device is a physical surgical suture, not a software algorithm. Therefore, there is no "standalone performance" in the context of an algorithm.

7. Type of Ground Truth Used:

Objective Measurement and Standards Compliance: The "ground truth" for this evaluation was based on objective measurements and adherence to established standards and predicate device performance.
- USP monograph for absorbable sutures: This serves as a "ground truth" or standard for tensile strength.
- Predicate device characteristics: The performance of the predicate device (Quill Synthetic Absorbable Barbed Suture, Quill™ Self-Retaining System (SRS) comprised of PDO) served as the comparative "ground truth" for barb holding strength and post-hydrolysis tensile testing.

8. Sample Size for the Training Set:

Not applicable. This device is a physical medical device (suture), not an AI/ML algorithm that requires a training set. The evaluation focuses on physical and mechanical properties.

9. How the Ground Truth for the Training Set Was Established:

Not applicable. As there is no training set for a physical device, this question is not relevant.

Summary

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510(k) Summary

Date Prepared:	November 27, 2013
Company:	Surgical Specialties Corporation100 Dennis Dr.Reading, PA 19606
Contact:	Kirsten StowellRegulatory Affairs ManagerPhone: 610-404-3367Fax: 610-404-3924Email: kstowell@angio.com

NOV 29 2013

Device trade name:	TranQuill barbed device, comprised of Polydioxanone
Device Common Name:	Polydioxanone Absorbable Surgical Suture
Device classification:	Absorbable polydioxanone surgical sutureProduct code, NEW21 CFR 878.4840Class II
Legally marketed device to which the device is substantially equivalent:	K051609:K080680 K080985
	Quill Synthetic Absorbable Barbed SutureQuill TM Self-Retaining System (SRS) comprised of PDOQuill TM Self-Retaining System (SRS) comprised of PDO
Description of the device:	The TranQuill barbed device is a sterile, synthetic absorbable device that is intended for use in the approximation of soft tissue. It is comprised of polyester [poly (p-dioxanone)], dyed with D&C Violet No. 2. The device is designed with small bi-directional barbs along the long axis of the suture monofilament. It is available in diameter Size 0 through 2-0 in various lengths affixed to various needle types.
Indications for Use:	The TranQuill barbed device comprised of dyed PDO is indicated for use in soft tissue approximation where use of absorbable sutures is appropriate.

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K133420 Page 2/2

Substantial The TranQuill barbed device comprised of polydioxanone has the Equivalence: same design and materials as the QuillTM Synthetic Absorbable Barbed Suture predicate device, including the same intended use and technological characteristics as the predicate device. The only difference between the proposed and predicate device is the decrease in spacing between barbs. Performance tests: Non-clinical laboratory performance testing was conducted to confirm that the TranQuill barbed device comprised of polydioxanone, conforms to the USP monograph for absorbable sutures for tensile strength (as applicable) and in vitro barb holding strength. This testing was performed in accordance with FDA's Class II Special Controls Guidance Document: Surgical Sutures, Issued June 3, 2003. Additional performance testing was conducted in order to demonstrate substantial equivalence to the predicate device including in vitro post-hydrolysis tensile testing. The results of this testing demonstrates that the TranQuill barbed

device comprised of polydioxanone, is substantially equivalent to the predicate device.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle or bird with three curved lines forming its body and wings. The bird is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the bird.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

Surgical Specialties Corporation Ms. Kirsten Stowell Regulatory Affairs Manager 100 Dennis Drive Reading, Pennsylvania 19606

January 23, 2014

Re: K133420

Trade/Device Name: TranQuill Barbed Device Regulation Number: 21 CFR 878.4840 Regulation Name: Absorbable polydioxanone surgical suture Regulatory Class: Class II Product Code: NEW Dated: November 6, 2013 Received: November 8, 2013

Dear Ms. Stowell:

This letter corrects our substantially equivalent letter of November 29, 2013.

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical

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Page 2 - Ms. Kirsten Stowell

device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 ), please contact the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely vours.

Joshua C. Nipper -S

Binita S. Ashar, M.D., M.B.A., F.A.C.S. Acting Director For Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on last page.

510(k) Number (if known) K133420

Device Name

TranQuill Barbed Device, comprised of Polydioxanone

Indications for Use (Describe)

The TranQuill barbed device comprised of polydioxanone, is indicated for soft tissue approximation where use of an absorbable suture is appropriate.

Type of Use (Select one or both, as applicable)

区 Prescription Use (Part 21 CFR 801 Subpart D)

[ ] Over-The-Counter Use (21 CFR 801 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

Regulation Number and Section

§ 878.4840 Absorbable polydioxanone surgical suture.

(a)
Identification. An absorbable polydioxanone surgical suture is an absorbable, flexible, sterile, monofilament thread prepared from polyester polymer poly (p-dioxanone) and is intended for use in soft tissue approximation, including pediatric cardiovascular tissue where growth is expected to occur, and ophthalmic surgery. It may be coated or uncoated, undyed or dyed, and with or without a standard needle attached.(b)
Classification. Class II (special controls). The special control for the device is FDA's “Class II Special Controls Guidance Document: Surgical Sutures; Guidance for Industry and FDA.” See § 878.1(e) for the availability of this guidance document.